CompletedNot SpecifiedObservational

Ultra-long-term EEG monitoring in people with intellectual disabilities

This study is about a new, small device called SubQ, which is placed just under the skin on your head. It's designed to help track brain activity continuously in people with learning disabilities who also have epilepsy or suspected seizures. Traditional ways of monitoring seizures can be difficult for these individuals, so this device aims to provide a more comfortable and continuous way to get information. The main goals are to see how well the SubQ device finds seizures, how safe it is, and if it makes a difference to people's quality of life and behaviour. Researchers also want to hear from carers and healthcare staff about their experiences and look at whether this technology could be a good value for money. Participants will have the device implanted, and their brain activity will be recorded, along with surveys about their well-being.

At a glance

Status

Completed

Phase

Not Specified

Sponsor

University of Plymouth

Enrolment target

Start

01 Nov 2024

Estimated completion

31 May 2026

Epilepsy and intellectual disability

What is this study about?

Many people with learning disabilities also experience seizures, but it can be really tricky to work out when they're happening and how best to manage them. The usual ways of checking brain activity, like an EEG, often involve lots of wires and can be uncomfortable, especially for someone who also has a learning disability. This can make it hard to get a clear picture of their seizures.

This study is trying out a new, very small device called SubQ. It's designed to sit just under the skin on your scalp and continuously record your brain activity. Think of it like a tiny, hidden tracker for your brain. The great thing is, once it's in place, it can do its job without you needing to stay in a hospital or have lots of fuss. The main aim is to see if this device can do a better job at spotting seizures and give doctors and families a clearer idea of what's happening.

Beyond just detecting seizures, the study also wants to understand the bigger picture. Researchers will look at whether the device is safe, if it makes a positive difference to people's daily lives and their mood, and how it might affect their behaviour. They'll also be talking to family members, carers, and doctors to gather their experiences, which is important for understanding if this new technology is truly helpful.

Key takeaways

This study uses a new, small device to track seizures in people with learning disabilities.
The device goes under the skin on the head, avoiding hospital stays for monitoring.
It aims for better seizure detection and understanding of how seizures affect behaviour.
The study also looks at safety, quality of life, and experiences of carers and doctors.
Participants must be adults (18+) with mild to moderate learning disabilities and epilepsy.
The study lasts about 7 months for each participant.

Who may be eligible?

This study is looking for adults aged 18 or over who have a learning disability (mild to moderate) and also experience epilepsy or suspected seizures. A very important part of being in the study is being able to understand what's involved and agree to take part yourself. You'd also need to be able to comfortably wear a practice device for a week or two before the actual device is fitted, just to make sure you're happy with it.

For family members or carers, you'd need to be willing to keep a seizure diary throughout the study. This helps compare how the device is working with what you observe daily. It's also helpful if there's information about seizures from the past six months. For healthcare professionals, your doctor specializing in epilepsy would need to recommend you for this type of long-term monitoring.

There are also some reasons why someone might not be able to join. For example, if you have certain medical conditions like a cochlear implant, active infections, or are very likely to have surgical problems. Also, people who might have an MRI scan during the study or are pregnant cannot take part.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Do you have a learning disability (mild to moderate)?
Do you have epilepsy or suspected seizures?
Can you understand what the study involves and agree to take part yourself?
Are you comfortable wearing a temporary device for about one to two weeks?

Answer every question to see your result.

What does participation involve?

If you decide to take part, the first step is to have the small UNEEG SubQ device carefully placed under the skin on your scalp. This is a minor procedure. Once the device is in, it will continuously record your brain activity. Throughout the study, you or your carer will also be asked to keep a diary of any seizures you experience. This helps the researchers compare the device's readings with what's actually happening.

To understand how the device affects daily life, you'll be asked to complete surveys about your behaviour and quality of life. These surveys will happen before the device is put in, shortly after, and then again after 3 and 6 months. For family members, carers, and healthcare staff involved, there will be opportunities to talk about your experiences with the device in group discussions. The study is expected to last about 7 months for each person, from start to finish.

Potential risks and benefits

Taking part in this study could offer several potential benefits. There's a chance the device could help detect seizures more accurately, which might lead to a better understanding of your condition and potentially better treatment plans. It could also give doctors more insight into how seizures affect your behaviour. However, like any procedure, there are some small risks. These mainly involve minor surgical risks from having the device implanted, such as a small chance of infection or discomfort where it's placed. Remember, you can decide to stop being part of the study at any time.

Locations (4)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Cornwall Partnership NHS Foundation Trust
City only
Bodmin, United Kingdom
The Royal Wolverhampton NHS Trust
City only
Wolverhampton, United Kingdom
Cardiff & Vale University Lhb
City only
Cardiff, United Kingdom
University Hospitals Plymouth NHS Trust
City only
Plymouth, United Kingdom

Common questions

What is the SubQ device?

It's a tiny device put under the skin on your scalp that continuously records your brain's electrical activity to help detect seizures.

Who can join this study?

Adults over 18 with mild to moderate learning disabilities and epilepsy, who can give their consent and meet other health criteria.

How long does the study last?

For each person, the study will last about 7 months from the start to the end.

Will I have to stay in hospital?

No, the device is designed to track brain activity without needing hospital stays for monitoring.

Who is paying for this study?

The study is funded by NHS England's Small Business Research Initiative (SBRI).

How to find out more

Edward Meinert

Edward.meinert@newcastle.ac.uk +44 (0)191 2336161 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.